Category Archive

Our DC-area readers interested in food and drug safety may want to attend this event.

Next Tuesday (1/12) at noon, Dr. Joshua M. Sharfstein, principal deputy commissioner for the FDA, will present, “Public Health and the FDA” here at the GW Hospital Auditorium (900 23rd St. NW, Foggy Bottom Metro). The event is part of Public Health Grand Rounds series hosted by the George Washington University School of Public Health and Health Services. Lunch will be provided.

I recently attended the June 29th-30th FDA advisory committee meeting that voted for a reduction in the maximum daily over-the-counter (OTC) dose of acetaminophen and the ‘unbundling’ of narcotic-acetaminophen prescription medications. While I agree ultimately with many of the recommendations that were made, I can’t help but feel that there is a larger problem that remains unaddressed. There is a growing disparity between FDA expectations for prescription drugs and expectations for OTC drugs and dietary supplements. As requirements for prescription drugs increasingly reflect the ability of the pharmaceutical industry to design and manufacture safer drugs, requirements for OTC drugs appear stagnant, and dietary supplements continue to be deemed safe until proven otherwise.

Most OTC painkillers were first made available at a time when modern drug development technologies and safety assessment techniques did not exist – and even though these technologies and techniques are now available, FDA hasn’t required OTC drug manufacturers to apply them to their products. The popularity of these drugs over the years has illustrated that the public considers them to be of great utility in offering readily available treatment for pain conditions. Yet, these drugs account for a huge proportion of the adverse events that are seen with all pharmaceutical agents, due in part to their widespread use. By all accounts (clinical trials, retrospective studies and medical surveillance systems) these compounds have ‘important’ health risks associated with their use, most notably to the liver, kidney and gastrointestinal tract. Not surprisingly, these adverse events constitute a substantial (and potentially avoidable) public safety issue with important implications in terms of health care costs.

This begs the question: do these drugs still reflect current safety and efficacy standards? And, shouldn’t they?

Among the problems with our country’s system of meat production is the routine use of antibiotics in livestock. Dosing the animals regularly helps them grow faster and survive cramped factory-farm conditions, which means cheap, abundant meat for consumers. The problem is that overusing antibiotics contributes to antibiotic resistance. Cheap meat doesn’t seem like such a bargain when more and more people are dying from antibiotic-resistant infections.

Representative Louise Slaughter (D-NY) has introduced the Preservation of Antibiotics for Medical Treatment Act of 2009 (HR 1549), which would ban animal uses of seven classes of antibiotics important to human health, and restrict the uses of other antibiotics in animals. The New York Times’ Gardiner Harris reports that opposition from the farm lobby makes this bill unlikely to pass on its own, but that the measure could be included in health reform legislation.

It is with deep sadness we inform you of the sudden passing of Kathyrn R Mahaffey, PhD. Kate had an exceptional and diverse career, with appointments at FDA, NIOSH, NIEHS and EPA. Most recently, Kate served as a Professorial Lecturer at the George Washington University School of Public Health.

Her husband, David Jacobs offers the following remembrance and tribute to her significant contributions to the public’s health. Information about a memorial service appears at the end of this post.

Kathryn R. Mahaffey passed away peacefully in her sleep June 2, 2009 after decades of work that advanced the nation’s health and environment. She is remembered as a beloved wife, mother, scientist and community member who served as a source of inspiration with her principled and tireless intellect. She was the rare scientist who knew how to apply the lessons from academic research to protect the public heath. Her work changed the face of epidemic heavy metal poisoning, endocrine disruptors and many other environmental pollutants that afflict children, pregnant women and at-risk populations. Literally millions of children have avoided the tragedy of lead and mercury poisoning as a consequence of her work.

I think it was around Christmastime last year, while frantically traipsing through the mall in search of bargains, that an over-eager kiosk salesperson stepped into my path. Wonderful, I thought. Another person trying to sell me overpriced hand cream. I tried to go around her, hoping she’d get the hint—to no avail. Oddly, instead of launching into a speech about my unhealthy cuticles, she asked me if I was a smoker.

And that’s when I noticed she was selling e-cigarettes: plastic cigarettes that look almost exactly like the real deal. (They even puff out odorless vapor that looks strikingly like cigarette smoke.) She explained to me that these can be a great tool for quitting smoking, because they look and feel like cigarettes. “It’s just like smoking, but without the nasty health effects.”

What a cool idea, I thought. My father, a former (heavy) smoker, told me once that quitting smoking was a total nightmare for him. Why? Because he didn’t just crave the nicotine in the cigarettes; he craved the whole smoking ritual: taking that first puff of the day while sipping his coffee, taking breaks at work and chatting with his friends, etc, etc. Quitting smoking wasn’t just about omitting nicotine from his life; it was about changing his lifestyle.

From that perspective, e-cigarettes seem like a good way to ease the transition from smoker to non-smoker. They look like cigarettes, taste like cigarettes, and feel like cigarettes but the “smoker” is no longer exposed to 40+ human carcinogens multiple times a day. On top of that, e-cigarettes don’t produce that thick, noxious cloud of smoke that clings to your hair, skin, and clothing, and makes everyone around you cough. “I feel like this could save my life,” said one satisfied customer, who reported cutting her smoking from 3 packs a day to 1 ½ packs a day.(1)

Alison Bass directs our attention to the tragic story of Denis Maltez, a 12-year-old Miami boy who died of serotonin syndrome after being given two anti-psychotic medications (Seroquel and Zyprexa) plus an anti-seizure drug and tranquilizer. Serotonin syndrome occurs when a combination of drugs causes the brain to produce excess serotonin. Denis had severe autism and was living in a Rainbow Ranch group home; the lawsuit just filed by his mother, Martha Quesada, says the drugs were used as a “chemical restraint to control Denis’s behavior.” Florida shut down Rainbow Ranch shortly after Denis’s death.

Denis is not the only child to have died after being given a cocktail of psychiatric drugs. In 2006, 4-year-old Rebecca Riley died from an overdose of drugs prescribed for bipolar disorder and ADHD. The Wall Street Journal’s David Armstrong reports that prescriptions of psychiatric drugs for children increased 44.6% between 2002 and 2007, and many of these drugs are not approved for use in children. The good news is that since Riley’s death, states are increasing scrutiny of psychiatric drugs prescribed for children, and this scrutiny is starting to have an effect. Armstrong writes:

Peanuts, pistachios, peppers (maybe tomatoes too), spinach, spices……….The list of produce recalled due to bacterial contamination gets longer, and baleful glances are cast at the Center for Food Safety and Applied Nutrition (CFSAN- say siff-san), the part of FDA charged with regulating the safety of those agricultural products.

With any luck, sometime during the next few years, the organization within CFSAN that deals with the safety of agricultural produce, the Office of Food Safety, will be moved over to a new food safety agency. Unfortunately, based on past history, CFSAN will continue to mis-regulate, under-regulate, or just ignore several important groups of products left behind when produce safety moves out. It’s worth taking a look at what will be left when food safety leaves, and it’s also worth taking long-overdue steps to improve FDA regulation of food additives, cosmetics and dietary supplements.

University of Maryland Law Professor Rena Steinzor called for fundamental changes to the role of OMB’s Office of Information and Regulatory Affairs (OIRA) in federal regulatory review, at a House Committee hearing held on April 30. The Subcommittee on Investigations and Oversight of the Committee on Science and Technology has been examining OIRA’s functions and responsibilities, with the chairman stating:

“…Though rarely in the headlines, OIRA has, in the years since its creation under President Reagan, quietly become the most powerful regulatory office in the Federal government.”

Professor Steinzor noted that the nomination of Cass Sunstein, President Obama’s choice for OIRA chief,* is looming, thus it is appropriate to examine the office’s function. Steinzor made three specific points:

As an academic epidemiologist I routinely do NIH funded research involving human subjects. That means my university must adhere to very strict regulations and guidelines for the protection of research subjects. Approval and monitoring of the ethical conduct of research funded by the Department of Health and Human Services (DHHS), of which NIH is a part, was made a legal requirement in the 1970s following widespread abuses, of which the Tuskeegee Syphilis Study and the experiments by Nazi doctors were the most notorious. But less flagrant ethical breeches were widespread in medical research. I was in medical school when Harvard anesthesiologist Henry Beecher’s New England Journal article (Beecher, H.K., Ethics and Clinical Research. New England Journal of Medicine. June 1966) on unethical medical research was published. It was like turning a switch in the medical community from almost total obliviousness to sudden realization.

Martin Keller is finally stepping down as the long time chief of psychiatry at Brown University. Brown University officials made the announcement in a Dear Colleagues letter dated today from Edward J. Wing, Brown’s new Dean of Medicine and Biological Sciences.

While Brown officials insist that the decision to step down was Keller’s, my understanding from several sources is that the university has been under pressure to take action ever since Side Effects was published last June and Sen. Charles Grassley began investigating Keller’s undisclosed conflicts of interest in July. Keller is the latest psychiatry kingpin to fall. In recent months, Stanford’s chief of psychiatry Alan Schatzberg and Emory University’s chief Charles Nemeroff were forced to step down after reports that they too failed to disclose years of lucrative financial payments from the pharmaceutical industry.

As I have reported in Side Effects and my blog here and here, Keller not only failed to disclose the millions of dollars he has received over the years from drug companies whose drugs he was studying and promoting in medical journals and at conferences. But there is evidence that Keller and his co-authors misrepresented data in a clinical trial of Paxil to make the antidepressant look safer and more effective than it really was. This trial, known as study 329 and funded by GlaxoSmithKline, was published in 2001 and used by the drug company to heavily market Paxil for off-label use in children and adolescents. Yet as it turns out, the data in this trial do not corroborate the company’s claims that Paxil was more effective than a placebo or sugar pill in treating depression in adolescents. The 2001 study also under-estimated the rate of suicidal thoughts and behaviors among participants taking Paxil in the study (in a 2006 paper, GlaxoSmithKline acknowledged that those taking the drug were five times more likely to be suicidal than those taking the placebo). GlaxoSmithKline is now under investigation by federal Department of Justice officials, and Keller himself has been deposed by attorneys in Boston’s U.S. attorney’s office, according to sources.Read the rest of this entry »